LifeVest Trends Validation Protocol (TRENDS)

ZOLL Medical

Status

Completed

Conditions

Heart Failure

Treatments

Device: Trends-equipped LifeVest 4000

Study type

Observational

Funder types

Industry

Identifiers

NCT02149290

90D0120

Details and patient eligibility

About

This study will evaluate the accuracy of data on body position, daily activity, heart rate, 6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator (WCD).

Full description

This is a multi-center validation study of heart failure patients wearing the LifeVest WCD modified to collect data on body position, activity, heart rate, 6-minute walk test, and a health survey in order to evaluate data accuracy and patient interactions with the device.

Enrollment

198 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Symptomatic heart failure (i.e., New York Heart Association (NYHA) class II or higher)
Evidence of a prior Myocardial Infarction (MI) or dilated cardiomyopathy
Ejection fraction of 35% or less at the start of WCD use
Anticipated to need a WCD for three months or more
At least 18 years of age (over the legal age of providing consent)

Exclusion criteria

Use of an implantable cardioverter defibrillator (ICD), recent removal of an ICD, or planned use of an ICD within the next three months
Need for an assistive device for ambulation (wheelchair, walker, or cane)
Use of a unipolar pacemaker
Physical or mental conditions that prevent interaction with or wearing of the device
Advanced directive prohibiting resuscitation
Pregnancy